Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age

Condition(s) targeted: Hepatitis A

Intervention: VAQTA® (Biological); Infanrix® (Biological); PedvaxHIB® (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Overall contact:
Toll Free Number, Phone: 1-888-577-8839

Hepatitis A vaccine will be given either alone or together with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine at the first dose. A second dose of hepatitis A vaccine will be given 6 months later. Response to the vaccines and safety data will be collected after each dose.

Official title: An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Hepatitis A Vaccine, Inactivated Given Concomitantly With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed in Healthy Children 15 Months of Age

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Antibody response of hepatitis A (4 weeks post dose 2), Hib (4 weeks postvaccination), and pertussis (4 weeks postvaccination). Safety profile of Hepatitis A Vaccine, Inactivated with other vaccines

Minimum age: 15 Months. Maximum age: 15 Months. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy males and females 15 months of age with no active liver disease and a negative

history of hepatitis A who have been vaccinated against Haemophilus influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases.

Exclusion Criteria:

- Males and females previously vaccinated with hepatitis A vaccine

- Any immune deficiency

- A history of allergy to any of the vaccine components

- A history of seizure disorder, or a bleeding disorder

Toll Free Number, Phone: 1-888-577-8839

Call for Information, Jonesboro, Arkansas 72401, United States; Recruiting

Call for Information, West Covina, California 91790, United States; Recruiting

Call for Information, Salinas, California 93901, United States; Recruiting

Call for Information, Paramount, California 90723, United States; Recruiting

Call for Information, Fresno, California 93726, United States; Recruiting

Call for Information, Buena Park, California 90620, United States; Recruiting

Call for Information, Centennial, Colorado 80112, United States; Recruiting

Call for Information, Norwich, Connecticut 06360, United States; Recruiting

Call for Information, Orlando, Florida 32806, United States; Recruiting

Call for Information, Lake Mary, Florida 32746, United States; Recruiting

Call for Information, Nampa, Idaho 83686-0000, United States; Recruiting

Call for Information, Idaho Falls, Idaho 83404, United States; Recruiting

Call for Information, DeKalb, Illinois 60115, United States; Recruiting

Call for Information, Topeka, Kansas 66614, United States; Recruiting

Call for Information, Kansas City, Kansas 66160, United States; Recruiting

Call for Information, Louisville, Kentucky 40291-0000, United States; Recruiting

Call for Information, Louisville, Kentucky 40202-3830, United States; Recruiting

Call for Information, Lexington, Kentucky 40503, United States; Recruiting

Call for Information, Stevensville, Michigan 49127, United States; Recruiting

Call for Information, Flint, Michigan 48503, United States; Recruiting

Call for Information, Brainerd, Minnesota 56401, United States; Recruiting

Call for Information, Bridgeton, Missouri 63044, United States; Recruiting

Call for Information, Princeton, New Jersey 08540, United States; Recruiting

Call for Information, Dayton, Ohio 45415, United States; Recruiting

Call for Information, Dayton, Ohio 45406, United States; Recruiting

Call for Information, Akron, Ohio 44308-1062, United States; Recruiting

Call for Information, Gibsonia, Pennsylvania 15044, United States; Recruiting

Call for Information, East Norriton, Pennsylvania 19401, United States; Recruiting

Call for Information, Columbia, South Carolina 29203, United States; Recruiting

Call for Information, Charleston, South Carolina 29406, United States; Recruiting

Call for Information, Houston, Texas 77087, United States; Recruiting

Call for Information, Houston, Texas 77084, United States; Recruiting

Call for Information, West Jordan, Utah 84088, United States; Recruiting

Call for Information, Salt Lake City, Utah 84107, United States; Recruiting

Call for Information, Huntington, West Virginia 25701, United States; Recruiting

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: April 2006
Last updated: October 29, 2008